INSPIRE Trial for Abdominal Infections
NCT05423743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198480
Last updated 2025-08-15
Summary
The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with abdominal infection is infected with a resistant pathogen.
Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.
Conditions
- Abdominal (ABD) Infection
Interventions
- OTHER
-
Arm 1: Routine Care
Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
- OTHER
-
Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection
Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having an abdominal infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.
Sponsors & Collaborators
-
Hospital Corporation of America
collaborator INDUSTRY -
University of California, Irvine
collaborator OTHER -
University of Massachusetts, Amherst
collaborator OTHER -
Brigham and Women's Hospital
collaborator OTHER -
Rush University
collaborator OTHER -
Harvard Pilgrim Health Care
lead OTHER
Principal Investigators
-
Shruti Gohil, MD, MPH · UC Irvine Division of Infectious Diseases
-
Susan Huang, MD, MPH · UC Irvine Division of Infectious Diseases
-
Richard Platt, MD, MS · Harvard Pilgrim Health Care Institute/Harvard Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-01
- Primary Completion
- 2025-05-09
- Completion
- 2025-05-09
Countries
- United States
Study Locations
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